FDA panel gives GSK’s Shingrix unanimous approval
pharmafile | September 14, 2017 | News story | Sales and Marketing | GSK, Shingrix, biotech, drugs, pharma, pharmaceutical, shingles
The FDA’s advisory panel has given a strong signal that GSK’s Shingrix should not have too much difficulty getting full FDA approval, after voting swung 11-0 in favour of recommending the vaccine.
The product protects those 50 years and older against shingles (herpres zoster) and could soon be competing with the only other product on the market, MSD’s Zostavax.
The signs look good for GSK that its vaccine will be able to become the dominant force in the market. Certain members of the advisory committee are reported to have said they were “very impressed” by the data and that the product is “a lot better than the vaccine we have now”.
Zostavax secured MSD $685 million in sales through 2016 but, due to the better data, analysts have Shingrix pegged to become a blockbuster seller by 2023.
Previous data from two Phase 3 trials showed that Shingrix provided protection against shingles in 90% of those aged 70 and over, this was also maintained for at least four years after treatment. This figure rose to 97% in people aged 50 and over.
The vaccine was also able to prevent postherpetic neuralgia (PHN), a problem associated with shingles, in 91% of those aged 50 and over, and in 89% of those aged 70 years and older.
Dr. Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D for GSK said: “Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles. Today’s vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system.”
Shingles is caused by the dormant chickenpox virus in those that had previously suffered from the condition, and results in a rash and blisters on the skin. It primarily impacts upon older members of the population whose immune systems become less able to mount a defence against the virus.
Though the condition usually fades after a few weeks, it can lead to PNH and the resulting pain can last for months or several years after the condition has faded.
With the unanimity of the decision and the strong data, it is expected that approval of the Shingrix vaccine could be announced in as little as a few weeks.
Ben Hargreaves
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